Nucala: First and only severe eosinophilic asthma biologic indicated from age 6¹

The licensed dose of Nucala in children aged 6-11 years is 40mg SC as a lyophilised powder, regardless of weight.¹

The safety profile of Nucala in paediatric patients was similar to that seen in adults²

Study 2003636 Part A: Adverse events in children aged 6-11 years
Number (%) of subjects³

AEs, n (%)³

 

Nucala
40 mg SC
n=26
Nucala
100 mg SC
n=10
Overall
Any AE
20 (77) 6 (60) 26 (72)
Related to study treatment 8 (31) 3 (30) 11 (31)
Leading to withdrawal 1 (4)
0 1 (3)
Any SAE 6 (23) 1 (10) 7 (19)
Related to study treatment 2 (8)
0 2 (6)
Fatal SAE 0 0 0
Any on-treatment AE 18 (69) 6 (60) 24 (67)
Any on-treatment serious AE 5 (19) 1 (10) 6 (17)

Study 2003636 Part B: Adverse events in children aged 6-11 years
Number (%) of subjects³

AEs, n (%) Nucala
40 mg SC
n=16
Nucala
100 mg SC
n=10
Nucala
40/100 mg SCa
n=4
Overall
n=30
Any AE
15 (94)
8 (80) 4 (100) 27 (90)
Related to study treatment 4 (25) 3 (30) 1 (25) 8 (27)
Leading to withdrawal 0 0 0 0
Any SAE 4 (25) 2 (20) 1 (25) 7 (23)
Related to study treatment 0 0 0 0
Fatal SAE 0 0 0 0
Any on-treatment AE 15 (94) 8 (80) 4 (100) 27 (90)
Any on-treatment serious AE 4 (25) 2 (20) 1 (25) 7 (23)

In this open-label, uncontrolled, repeat-doseextension study, children aged 6-11
years with severe asthma with an eosinophilic phenotype received a body weight-dependent dose of SC Nucala of 40mg (<40kg) over 52 weeks.²

Explore efficacy data

Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.¹

Nucala is generally well tolerated. In clinical trials, Nucala had a similar incidence of adverse events vs. placebo with the exception of injection site reactions (8% vs. 3%), which occurred mainly within the first 3 injections.¹

The long-term safety and immunogenicity profile of Nucala was similar to that observed in placebo-controlled asthma trials.⁴

The recommended dose of Nucala is 100mg SC once every 4 weeks in adults and adolescents 12 years and older, available in a pre-filled pen, pre-filled syringe or lyophilised powder. The licensed dose of Nucala in children aged 6-11 years is 40mg SC regardless of weight and available in lyophilised powder. The pre-filled formulations are are not indicated in 6-11 year olds.¹

SC, subcutaneously;

References

  1. Nucala SmPC 2020
  2. Stienfield J et al. Am J Respi Crit Care Med 2019; 199:A7192.
  3. GlaxoSmithKline data on file. REF-35199
  4. Khurana S et al. Clin Ther 2019; 41:2041-2056

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441

© 2020 GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.

PM-GB-MPL-WCNT-200033 | November 2020